7th Aseptic Processing Summit 2024 | Vonlanthen Group of Companies | 19 November 2024 | Hotel NH Collection München Bavaria, Arnulfstraße 2, 80335 München, Germany

The demand for aseptic manufacturing is on the rise, presenting increasingly complex challenges in processing.

Accessing EU GMP Annex 1, pharmaceutical companies face new operational hurdles, necessitating technical and organizational adaptations.

At the upcoming summit, industry experts will illuminate the requisites for robust aseptic processing, offering targeted implementation strategies.

Aseptic processing in pharmaceuticals involves specific challenges and technologies tailored to the stringent requirements of drug manufacturing. Here are the key problems and challenges specific to pharmaceutical aseptic processing:

Problems and Challenges:
• Sterility Assurance:
Stringent Sterility Requirements: Pharmaceutical products must meet very high sterility standards. Any contamination can have severe consequences for patient safety.
• Regulatory Compliance:
Regulatory requirements from agencies like the FDA, EMA, and other global bodies are continuously evolving. Keeping up with these changes requires ongoing adaptation and updates to processes and documentation.
• Product and Process Validation:
Validating aseptic processes is complex and involves extensive testing, including media fill tests, to ensure the process can consistently produce sterile products.
• Cross-Contamination Risks:
Handling high-potency active pharmaceutical ingredients (APIs) poses significant risks of cross-contamination and requires specialized containment strategies.
• Supply Chain Integrity:
Ensuring that raw materials and components (e.g., stoppers, vials) are sterile and free from contaminants is critical and requires stringent supplier controls.
By integrating new technologies, pharmaceutical manufacturers can enhance the sterility assurance of their aseptic processes, improve compliance with regulatory requirements, and increase the efficiency and reliability of their production operations:

New Technologies:
• Advanced Sterilization Techniques
• Isolator and Barrier Systems
• Single-Use Systems
• Real-Time Monitoring and Control
• Automation and Robotics
• Innovations in Packaging and Delivery Systems
• Enhanced Cleanroom Design

As the demand for aseptic manufacturing continues to rise, the complexities and challenges in aseptic processing have become increasingly intricate. Pharmaceutical companies, accessing the EU GMP Annex 1, are confronted with new operational hurdles that necessitate both technical and organizational adaptations.

Key Practical Learning Points:
• Navigate the challenges of aseptic processing in alignment with Annex 1 regulations for the Manufacture of Sterile Medicinal Products
• Embrace innovative aseptic processing technologies while addressing regulatory concerns and expectations
• Learn strategies to avoid common pitfalls during aseptic manufacturing inspections and understand the future of GMPs in this context
• Overcome hurdles in adopting new technologies for safe and highly potent aseptic production
• Utilize automation, robotics, virtual reality, artificial intelligence, machine learning, and predictive modeling to model, predict, and control aseptic processes more effectively
• Design, develop, and implement components in aseptic manufacturing processes to ensure efficiency and compliance
• Establish robust contamination control strategies leveraging advancements in technology
• Navigate the specific requirements of highly potent manufacturing
• Develop and qualify aseptic manufacturing processes for Advanced Therapy Medicinal Products (ATMPs), including cell and gene therapies, and mRNA vaccines
• Embrace risk-based approaches to process design and control for enhanced efficiency and safety
• Explore key insights and implementations for ensuring sterility assurance of finished products

2024 Speakers

Richard Denk
Senior Consultant, Aseptic Processing & Containment, Skan AG, CH

James L. Drinkwater
Head of GMP Compliance, Honorary Member and Ex-Chairman of PHSS, Franz Ziel GmbH, DE

Dr. Anne Orillo
Site Validation Lead, Novartis, CH

Sergio Cuevas Luján
Packaging Materials Engineer, Boehringer Ingelheim, ES

Alberto Gonzalez
Global Sterility Assurance Associate Director, Takeda, ES

Steve Marnach
EMEA Training Manager & Critical Environments Specialist, DuPont de Nemours, LU

Jingjing Li
Associate Director, Global Quality Compliance, Orchard Therapeutics, UK

Dr. Gilberto Dalmaso
Owner, GDM Pharma Consulting, IT

Dennis Duerr
Process Validation Engineer, Roche, DE

Alan Kelly
Subject Matter Expert (Aseptic Fill Finish), PM Group, UK

Terri Love
Senior BioManufacturing Engineer, Merck, IR

Dr. Ulrich Herber
Senior Director, Scientific Portfolio Management – Microbial Solutions, Charles River – Microbial Solutions, DE

Ruben van der Galiën
Qualified Person / QA Specialist, GE HealthCare, NL

James Smith
Applications Scientist, Croda Europe, UK

Dr. Eveline-Marie Lammens
Senior Specialist L&D – IPT Steriele, Organon Benelux, BE

Di Morris
Qualified Person / QA Compliance Advisor, PNR Pharma, UK

2024 Sponsor

• Tempris